Safety data sheet according to 1907/2006/EC, Article 31

Transcription

1 Page 1/7 1 Identification of the substance/mixture and of the company/undertaking Product identifier Article number: 036-B Registration number Not applicable Application of the substance / the preparation Resin-based adhesive for orthodontics Details of the supplier of the safety data sheet Manufacturer: Kuraray Europe GmbH Philipp-Reis-Str. 4, Hattersheim am Main Germany Phone:+49 (0) Fax:+49 (0) dental@kuraray.de Supplier: J & S Davis Further information obtainable from: Manufacturer or Supplier Emergency telephone number: National Poisons information Service (London Centre) Guy s & St. Thomas Hospital Trust Medical Toxicology Unit Avonley Road LONDON SE14 5ER Emergency telephone: (local) or Administrative telephone: Facsimile number: Hazards identification Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 GHS07 Acute Tox. 4 H302 Harmful if swallowed. Skin Irrit. 2 H315 Causes skin irritation. Eye Irrit. 2 H319 Causes serious eye irritation. Skin Sens. 1 H317 May cause an allergic skin reaction. STOT SE 3 H335 May cause respiratory irritation. Classification according to Directive 67/548/EEC or Directive 1999/45/EC Xn; Harmful R22: Harmful if swallowed. Xi; Irritant R36/37/38: Irritating to eyes, respiratory system and skin. Xi; Sensitising (Contd. on page 2)

2 Page 2/7 R43: May cause sensitisation by skin contact. (Contd. of page 1) R31: Contact with acids liberates toxic gas. Information concerning particular hazards for human and environment: The product has to be labelled due to the calculation procedure of the "General Classification guideline for preparations of the EU" in the latest valid version. Classification system: The classification is according to the latest editions of the EU-lists, and extended by company and literature data. Label elements Labelling according to Regulation (EC) No 1272/2008 The product is classified and labelled according to the CLP regulation. Hazard pictograms GHS07 Signal word Warning Hazard-determining components of labelling: sodium fluoride 2-hydroxyethyl methacrylate Hazard statements H302+EUH031 Harmful if swallowed. Contact with acids liberates toxic gas. H315 Causes skin irritation. H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. H335 May cause respiratory irritation. Precautionary statements P261 Avoid breathing dust/fume/gas/mist/vapours/spray. P280 Wear protective gloves/protective clothing/eye protection/face protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P321 Specific treatment (see on this label). P405 P501 Store locked up. Dispose of contents/container in accordance with local/regional/national/international regulations. Other hazards Results of PBT and vpvb assessment PBT: Not applicable. vpvb: Not applicable. 3 Composition/information on ingredients Chemical characterization: Mixtures Description: Mixture of substances listed below with nonhazardous additions. Dangerous components: CAS: EINECS: CAS: EINECS: CAS: EINECS: triethylene glycol dimethacrylate Xi R36/37/38 Skin Irrit. 2, H315; Eye Irrit. 2, H319; STOT SE 3, H335 2-hydroxyethyl methacrylate Xi R36/38; Xi R43 Skin Irrit. 2, H315; Eye Irrit. 2, H319; Skin Sens. 1, H317 bisphenol A diglycidylmethacrylate Xi R36/38 Skin Irrit. 2, H315; Eye Irrit. 2, H % 5-25% <10% (Contd. on page 3)

3 Page 3/7 CAS: EINECS: sodium fluoride T R25; Xi R36/38 R32 Acute Tox. 3, H301; Skin Irrit. 2, H315; Eye Irrit. 2, H319 Other ingredients: Methacryloylfluoride-methyl methacrylate copolymer Silanated colloidal silica dl-camphorquinone Accelerators Others (Contd. of page 2) <10% 4 First aid measures Description of first aid measures General information: Symptoms of poisoning may even occur after several hours; therefore medical observation for at least 48 hours after the accident. After inhalation: Supply fresh air and to be sure call for a doctor. In case of unconsciousness place patient stably in side position for transportation. After skin contact: Immediately wash with water and soap and rinse thoroughly. After eye contact: Rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor. After swallowing: Do not induce vomiting; call for medical help immediately. Call for a doctor immediately. Information for doctor: Most important symptoms and effects, both acute and delayed No further relevant information available. Indication of any immediate medical attention and special treatment needed No further relevant information available. 5 Firefighting measures Extinguishing media Suitable extinguishing agents: CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. Special hazards arising from the substance or mixture No further relevant information available. Advice for firefighters Protective equipment: Wear fully protective suit. Mouth respiratory protective device. 6 Accidental release measures Personal precautions, protective equipment and emergency procedures Mount respiratory protective device. Environmental precautions: Do not allow to enter sewers/ surface or ground water. Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). Dispose contaminated material as waste according to item 13. Reference to other sections See Section 7 for information on safe handling. See Section 8 for information on personal protection equipment. (Contd. on page 4)

4 Page 4/7 See Section 13 for disposal information. (Contd. of page 3) 7 Handling and storage Handling: Precautions for safe handling Ensure good ventilation/exhaustion at the workplace. Prevent formation of aerosols. Information about fire - and explosion protection: No special measures required. Conditions for safe storage, including any incompatibilities Storage: Requirements to be met by storerooms and receptacles: Store in a refrigerator (2-8 C). Information about storage in one common storage facility: Store away from oxidizing agents. Store away from reducing agents. Do not store together with acids. Further information about storage conditions: Keep container tightly sealed. Store in cool, dry conditions in well sealed receptacles. Protect from heat and direct sunlight. Specific end use(s) No further relevant information available. 8 Exposure controls/personal protection Additional information about design of technical facilities: No further data; see item 7. Control parameters Ingredients with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. Additional information: The lists valid during the making were used as basis. Exposure controls Personal protective equipment: General protective and hygienic measures: Immediately remove all soiled and contaminated clothing Wash hands before breaks and at the end of work. Avoid contact with the eyes and skin. Respiratory protection: In case of brief exposure or low pollution use respiratory filter device. In case of intensive or longer exposure use self-contained respiratory protective device. Protection of hands: Protective gloves The glove material has to be impermeable and resistant to the product/ the substance/ the preparation. Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/ the chemical mixture. Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation Material of gloves (Contd. on page 5)

5 Page 5/7 (Contd. of page 4) The selection of the suitable gloves does not only depend on the material, but also on further marks of quality and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the application. Penetration time of glove material The exact break trough time has to be found out by the manufacturer of the protective gloves and has to be observed. Eye protection: Tightly sealed goggles 9 Physical and chemical properties Information on basic physical and chemical properties General Information Appearance: Form: Liquid Colour: Transparent Yellow Odour: Odourless ph-value: Not applicable Change in condition Melting point/melting range: Boiling point/boiling range: -12 C (2-hydroxyethyl methacrylate) 205 C (2-hydroxyethyl methacrylate) Flash point: 97 C (2-hydroxyethyl methacrylate) Ignition temperature: Not applicable Danger of explosion: Product does not present an explosion hazard. Explosion limits: Lower: Upper: Not applicable Not applicable Vapour pressure: Not applicable Density: 1.2 g/cm³ Vapour density Not applicable Solubility in / Miscibility with water: Not miscible or difficult to mix. Segregation coefficient (n-octanol/water): Not applicable Other information No further relevant information available. 10 Stability and reactivity Reactivity Chemical stability Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications. Possibility of hazardous reactions No dangerous reactions known. Conditions to avoid No further relevant information available. Incompatible materials: No further relevant information available. (Contd. on page 6)

6 Page 6/7 Hazardous decomposition products: Carbon monoxide and carbon dioxide (Contd. of page 5) 11 Toxicological information Information on toxicological effects Acute toxicity: LD/LC50 values relevant for classification: hydroxyethyl methacrylate Oral LD mg/kg (guinea pig) 3275 mg/kg (mouse) 5050 mg/kg (rat) sodium fluoride Oral LD50 44 mg/kg (mouse) 52 mg/kg (rat) Primary irritant effect: on the skin: Irritant to skin and mucous membranes. on the eye: Irritating effect. Sensitization: Sensitization possible through skin contact. Additional toxicological information: The product shows the following dangers according to the calculation method of the General EU Classification Guidelines for Preparations as issued in the latest version: Harmful Irritant 12 Ecological information Toxicity Aquatic toxicity: No further relevant information available. Persistence and degradability No further relevant information available. Behaviour in environmental systems: Bioaccumulative potential No further relevant information available. Mobility in soil No further relevant information available. Additional ecological information: General notes: Water hazard class 1 (German Regulation) (Self-assessment): slightly hazardous for water Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system. Results of PBT and vpvb assessment PBT: Not applicable. vpvb: Not applicable. Other adverse effects No further relevant information available. 13 Disposal considerations Waste treatment methods Recommendation Must not be disposed together with household garbage. Do not allow product to reach sewage system. Uncleaned packaging: Recommendation: Disposal must be made according to official regulations. (Contd. on page 7)

7 Page 7/7 (Contd. of page 6) 14 Transport information UN-Number ADR, ADN, IMDG, IATA Void UN proper shipping name ADR, ADN, IMDG, IATA Void Transport hazard class(es) ADR, ADN, IMDG, IATA Class Void Packing group ADR, IMDG, IATA Void Environmental hazards: Marine pollutant: No Special precautions for user Not applicable. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code UN "Model Regulation": - Not applicable. 15 Regulatory information Chemical safety assessment: A Chemical Safety Assessment has not been carried out. 16 Other information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. Version: 4 Relevant phrases H301 Toxic if swallowed. H315 Causes skin irritation. H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H335 May cause respiratory irritation. R25 Toxic if swallowed. R32 Contact with acids liberates very toxic gas. R36/37/38 Irritating to eyes, respiratory system and skin. R36/38 Irritating to eyes and skin. R43 May cause sensitisation by skin contact.